DURYSTA INTRACAMERAL IMPLANT

 

Allergan’s DURYSTA biodegradable intracameral implant is the first sustained release device approved by the FDA.

The device is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHTN).

DURYSTA is composed of biodegradable polymers containing 10 mcg of bimatoprost designed to release the drug in a non-pulsatile, steady-state manner over a 90-day period.

Bimatoprost is a prostaglandin analogue which lowers IOP by increasing aqueous humor outflow via both the conventional trabecular route as well as the uveoscleral pathway.

The agent may also increase aqueous humor outflow by decreasing episcleral venous pressure.

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The DURYSTA implant is preloaded within a sterile applicator with a 28-gauge needle tip. Under aseptic conditions, the practitioner inserts the needle into clear cornea, enters the anterior chamber, and then depresses an actuator button to release the implant. Following release of the implant, the needle is removed and the patient is instructed to sit upright for at least one hour so that the implant can rest in the inferior part of the anterior chamber.

Placement of the implant within the anterior chamber angle allows for close proximity to the tissues involved in both of the outflow pathways, where it delivers bimatoprost 24/7 for several months.

A single administration of the bimatoprost implant was found to control IOP in 40% of patients for up to 12 months and in 28% of patients for up to 24 months.

DURYSTA is contraindicated in patients with: active or suspected ocular or periocular infections; corneal endothelial cell dystrophy (e.g., Fuchs’ Dystrophy); prior corneal transplantation or endothelial cell transplants (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]); absent or ruptured posterior lens capsule, due to the risk of implant migration into the posterior segment; hypersensitivity to bimatoprost or to any other components of the product.

The commonest adverse effect reported is conjunctival hyperemia, seen in 27% of patients. Other side-effects are foreign body sensation, eye pain, photophobia, conjunctival hemorrhage, dry eye, eye irritation, increased IOP, corneal endothelial cell loss, blurred vision, iritis, and headache.

Ocular adverse reactions occurring in 1-5% of patients were anterior chamber cell, lacrimation increased, corneal edema, aqueous humor leakage, iris adhesions, ocular discomfort, corneal touch, iris hyperpigmentation, anterior chamber flare, anterior chamber inflammation, and macular edema.

As with other PG analogues, DURYSTA can cause permanent iris pigmentation.

DURYSTA should be used with caution in patients with narrow iridocorneal angles (Shaffer grade < 3) or anatomical obstruction (e.g., scarring) that may prohibit settling in the inferior angle.

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